Treatment > Retinoids · Temozolomide Clinical Trials

Meeting Abstract

Neoadjuvant therapy with temozolomide and 13-cis-retinoic acid in high grade glioma - a phase II-study

Klaus Fabel, Peter Hau, Oliver Grauer, Tanya Jauch, Martin Proescholdt, Anton Zellner, Andreas Steinbrecher, Alexander Brawanski, Ulrich Bogdahn

University of Regensburg, Regensburg, Germany

Purpose. A number of studies have evaluated the benefit of neoadjuvant chemotherapy after resection in high grade glioma (WHO grade III or IV). 
Nevertheless, a clear benefit concerning median time to progression or median overall survival could not be shown yet. Besides that, a phase II-study in recurrent high grade glioma published recently has shown significant benefit under combined treatment with temozolomide and 13-cis-retinoic acid (Jaeckle et al., 2000). 

Patients and Methods. Therefore, we initiated a phase II-protocol with a neoadjuvant combined therapy consisting of temozolomide 200 mg/m2 BS day 1-5 in 28 days and 13-cis-retinoic acid 60 mg/m2 BS day 1-21 in 28 days until tumor progression. 
Patients were followed closely with clinical and imaging (MRI) follow up every 4 weeks. 
Primary end point was tumor progression. 
In the case of clinical or radiological relapse, a second surgery was performed, if possible, and radiotherapy was initiated. 

Results. Eleven patients with high grade glioma (n=5, glioblastoma; n=1, gliosarcoma, n=2, anaplastic oligoastrocytoma; n=3, anaplastic oligodendroglioma) have been included at this point. 
Six patients, all with glioblastoma, are evaluable for tumor progression. 
They had progressive disease after 1, 1, 1, 3, 6, and 9 cycles of therapy. 
Of the patients with grade III-tumors, 2 are stable for 4 and 8 cycles of therapy now. 
The other patients are to early for evaluation. 

Conclusion. At this point, it is to early to draw definite conclusions about efficacy in this phase II-trial. 
Of the patients with glioblastoma treated so far, the major part (4/6, 66%) progressed rapidly during the first 3 cycles of therapy. 
Nevertheless, patients with grade III-tumors may benefit significantly from this combined approach.

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